Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery (MCToCM)
|Glaucoma||Device: Use of ologen Collagen Matrix in trabeculectomy (ologen) Drug: Use of Mitomycin-C (MMC) in trabeculectomy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery|
- Intraocular pressure(IOP) reduction [ Time Frame: At postoperative up to 24 months. ]
"Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP.
Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size.
"Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters.
In the specified time frame, patients will also visit for record at day 1, 7, 14, 30, 90, 180 days, 12, 18, and 24 months.
- Postoperative complications and appearances [ Time Frame: At postoperative up to 24 months. ]
Inspections of hyphema, severe anterior chamber reaction, hypotony, supercholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak.
Visual acuity, bleb appearance, and anterior chamber inflammation.
|Study Start Date:||February 2010|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: ologen Collagen Matrix
When performing glaucoma surgery, a trabeculectomy, use ologen Collagen Matrix instead of MMC before closing the conjunctiva
Device: Use of ologen Collagen Matrix in trabeculectomy (ologen)
Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
Active Comparator: Mitomycin-C (MMC)
When performing glaucoma surgery, a trabeculectomy, use MMC as antifibrotic agent before closing the conjunctiva
Drug: Use of Mitomycin-C (MMC) in trabeculectomy
After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.
"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study.
Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.
The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440751
|United States, Arkansas|
|VoldVision-Holf Eye Clinic|
|Rogers, Arkansas, United States, 72756|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, New Jersey|
|Institue of Ophthalmology and Visual Science|
|Newark, New Jersey, United States, 07103|
|United States, New York|
|Glaucoma Associates of New York|
|New York, New York, United States, 10003|
|New York Eye and Ear Infirmary|
|New York, New York, United States, 10003|
|United States, Oklahoma|
|Dean McGee Eye Institue|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Wills Eye Institue|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Glaucoma Associates of Texas|
|Dallas, Texas, United States, 75231|
|Principal Investigator:||Robert Ritch, MD||Glaucoma Associates of New York|
|Study Director:||Steven Sarkisian, MD||Dean McGee Eye Institute|
|Study Director:||Robert Fechtner, MD||Institute of Ophthalmology and Visual Science|
|Study Director:||Michael Pro, MD||Wills Eye Institue|
|Study Director:||Steven Vold, MD||Boozman-Hof Eye Clinic|
|Study Director:||Angelo Tanna, MD||Northwestern Memorial Hospital|
|Study Director:||David Godfrey, MD||Glaucoma Associates of Texas|
|Study Director:||Paul Sidoti, MD||New York Eye and Ear Infirmiry|